BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3011786 · Received March 19, 2013

    Report

    Report Number
    2955842-2013-00906
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    August 30, 2012
    Report Date
    February 20, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    RECEIVED MEDWATCH REPORT FROM THE CUSTOMER, ACCORDING TO THE MDR REPORT, 'FENESTRATED BIPOLAR INSTRUMENT HAD A MISALIGNED JAW FROM A DEFECTIVE FREYED CABLE. NOT OBVIOUS PATIENT HARM.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113436 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES